Legal Perspectives on Research Misconduct in Academia and Industry

When an academic institution or life sciences company becomes aware of allegations of research misconduct (i.e., fabrication or falsification of data and/or images, and plagiarism) relating to their researchers, a challenging and time-intensive process of review typically ensues. Academic institutions frequently utilize the detailed investigational framework that is required when the allegation relates to federally funded research, while life sciences companies typically are not restricted by these requirements but nevertheless have additional relevant legal and ethical obligations (for example, securities law, FDA and EMA submission implications, and published scientific papers). Throughout the process, issues of privacy, confidentiality, and reputation must be addressed. This session will deal with some of the most vexing problems in complex research misconduct cases, especially those that lie at the intersection of industry and academia.

Attendees discussed the most vexing problems in complex research misconduct cases, especially those that lie at the intersection of industry and academia. For example, how should an academic institution investigate research misconduct allegations in research collaborations between in-house industry labs/scientists and academic investigators? What are the attendant liability risks for informing or not informing the successor employer of a scientist who has been found to have engaged in research misconduct?

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